Shanghai-based Micurx Pharmaceuticals Inc. is preparing to file an NDA for its lead antibacterial candidate, contezolid, with China's National Medical Products Administration after results of a pivotal phase III trial there showed the drug providing comparable clinical cure rates to linezolid for complicated skin and soft tissue infections (cSSTI). Reduced hematologic toxicity for the tablet-based antibiotic vs. linezolid was also seen, highlighting one of contezolid's key advantages.

DUBLIN – Shares in Polyphor AG dropped as much as 21% Wednesday as the company shut down two phase III trials of its lead drug candidate, murepavadin, a first-in-class intravenous antibiotic in development for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

It has been acknowledged by governments around the world that there are simply not enough antibiotics currently in the product pipeline to meet the predicted requirements of their health care systems. Not good news considering that antibiotic resistance continues to be a major societal concern, with the CDC estimating that in the U.S. alone at least 2 million people contract an antibiotic-resistant infection, and at least 23,000 people die annually as a result.

NEW YORK – While listening to panelists during the BIO CEO & Investor conference discuss the current state of the opioid epidemic, it occurred to me that there was something about this narrative that seems familiar. I feel like I’ve written this story before. And I have. About 10 or 12 years ago. Only then, instead of pain drugs, it was antibiotics. Despite the need for new antimicrobial treatments to combat the growing resistance problem, many companies were shying away from antibiotic drug development. Part of that was due to the shifting regulatory landscape at the FDA regarding noninferiority studies....

I’m terrified of hospitals. Not so many years ago, this would have been an absurd remark. With doctors and high-tech medical care all around, a hospital seemed like one of the safer places in the world to be. But then, not so many years ago, age-related macular degeneration likely would have blinded many patients, as it did my late grandfather, pre-Macugen, pre-Lucentis. Things change, and not always for the better. The rise of resistant infections, especially the hospital-haunting and deadly methicillin-resistant Staphylococcus aureus (MRSA) has kept drug developers scrambling for new weapons against this bug and others. Until lately, the...

Look! Up in the sky! It’s a bird! It’s a plane! It’s . . . another superbug. The invasion of the multidrug-resistant superbugs is not a nightmare in the making. It’s already here. And it could be years before a new superhero lands in Metropolis to knock out the worst of the worst of these villains that are set on world domination. In a twist on the usual comic book tale, the super-resistant strains of CRE, malaria and tuberculosis threatening the world today are not the work of a mad scientist scheming away in a remote underground lab. They are...

What’s the difference between Congress and a Rube Goldberg contraption? They both use convoluted processes to accomplish a simple task, but the Goldberg invention still manages to keep the end result pretty simple. And while there may be some unintended consequences with both, they’re not unexpected with the absurd processes of a Goldberg machine. One look shows you what kind of mess you’re going to have if the cracker misses its mark, the parrot misses its perch, the seeds miss the bucket, the cigar lighter misses the fuse . . . Not so with Congress. By the time all 435...